Status:

COMPLETED

Two-site Intradermal Influenza Vaccination in Elderly

Lead Sponsor:

Queen Saovabha Memorial Institute

Conditions:

Influenza

Eligibility:

All Genders

60-100 years

Phase:

NA

Brief Summary

One-site dose sparing intradermal influenza vaccination in elderly had been studied but resulted in unsatisfactory outcomes. The investigators evaluate the safety and immunogenicity of the two-site in...

Detailed Description

The subjects would be randomly divided into three groups of 60 subjects each. Group1 receives a single intramuscular dose of 0.5 ml of trivalent influenza vaccine, containing at least 15 microgram of ...

Eligibility Criteria

Inclusion

  • healthy male or female volunteer aged at least 60 years old
  • willing to participate in this study

Exclusion

  • previous influenza vaccination within 6 months
  • systemic ypersensitivity to egg or chicken proteins or any of the vaccine components
  • history of a life-threatening reaction to the study vaccine or a vaccine containing the same constituents.
  • ongoing acute febrile illness (oral temperature, ≥37.5 c )
  • congenital or acquired immunodeficiency
  • treatment with immunosuppressive or other immune- modifying drugs or cancer therapy within previous 6 months
  • long-term treatment with systemic corticosteroids
  • receipt of blood or blood-derived products in the previous 3 months
  • history of thrombocytopenia or a bleeding disorder contraindicating for intramuscular vaccination.

Key Trial Info

Start Date :

October 1 2010

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 1 2018

Estimated Enrollment :

180 Patients enrolled

Trial Details

Trial ID

NCT01202552

Start Date

October 1 2010

End Date

April 1 2018

Last Update

April 6 2018

Active Locations (1)

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1

Queen Saovabha Memorial Institute

Bangkok, Thailand, 10330